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 December 2003 NCSAC Meeting Summary: Asthma

Appendix IV: National Children’s Study Advisory Committee 8th Meeting

Thematic Group Breakout Meeting Summary: Asthma

December 15, 2003
Sheraton Atlanta Hotel
Atlanta, GA

Chair: Grace LeMasters, Ph.D. NCSAC Member, University of Cincinnati

Dr. LeMasters opened the meeting by stating the task: to explore the determinants causing outcomes in the hypotheses of the National Children’s Study­ asthma thematic group. She suggested discussing Study outcomes based on external, internal, social, and biological factors. The group approached the task by first defining outcomes at every stage to be measured, including during pregnancy and every year up to five years of age. They then discussed what exposures they wanted to measure in relation to time and outcomes for hypotheses including indoor/outdoor air pollution, respiratory/viral infections, and bacterial/microbial products. They evaluated these in terms of both adverse and possible positive exposures (the hygiene hypothesis).

Jesse Marquez, Coalition for a Safer Environment, raised an objection to the narrow use of the disorder of Asthma as a concentration for the Study. He suggested that the Study theme include “all reactive airway diseases.”

Stephanie London, M.D., NIEHS, and Fernando Martinez, M.D., University of Arizona, both assured the group that the Study focus uses the term “Asthma” as a general umbrella term in order to effectively define all reactive airway diseases. They instructed that a reference to respiratory-obstruction generally guides the Study to concentrate on Asthma as the resulting medical term.

After discussion, the group decided to recommend that the thematic area be expanded to include airway reactive disease, allergies, and asthma.

Specificity of Asthma Study Hypotheses

Outcome Measures

  • Questionnaire for parents––diary may be burden for parents
  • Symptoms of asthma measures for children
    • Prenatal
      • Three dimensional ultrasound
      • Amniotic fluid
      • Placental biopsy
      • Standardized measures for indicating outcomes of asthma
      • Collecting data
      • Gestational age.
    • At birth
      • First year of life outcome measures should be determined every two (2) months (asthma)
      • APGAR scores
      • Respiratory rate
      • Mode of delivery
      • Breath measure
      • Amniotic fluid
      • Size (length, chest circumference, head circumference, leg length, crown measurements)
      • Birth complication–neonatal respiratory disease
      • Oxygen saturation
      • Birth weight.
    • Measure of exposure for parents and infants
      • Exhaled condensation
      • Prenatal
      • history
      • Breath measure
      • Childcare, day care, Head Start
      • Diet (breast milk, formula)
      • Nutrition.

Recommendations

  • Loretta Jones, M.A., Healthy African American Families, noted that test taking logistics for 20 years will result in a burden on human subjects. Phone calls were suggested instead of clinical visits.
  • Dr. Martinez brought up the question of the reliability of the parental responses (for example, wheezing or cough is bad).
  • Ms. Jones mentioned the need for well baby check-ups. Doctors London and Martinez suggested a check-up at six weeks, two months, six months, nine months, and one year. All encounters that have a respiratory impetus must be noted and recorded for the Study. It was suggested that those children not seen for well-baby visits should have blood samples drawn.

Critical Issues

  • Preconception
  • Prenatal
  • Maternal
  • Paternal
  • Neonatal.

Finalizing Study Hypotheses on Asthma for the Critical Issues

  • First year outcomes
    • Collect blood 2 ml. at six to nine months (at least once in order to register lymphocytes and leukocytes)
    • Exhaled condensation
      • Collect on baby’s tube
      • Cytokines, etc.
      • Child sleeping.
    • Heart rate variability (if possible)
      • Autonomic variability.
    • Allergy testing at age 1 and over
      • Touch of skin
      • Requires trained individual
      • Obtain blood.
    • At 16 months, 20 months, 24 months
      • Use questionnaire
      • Use well child clinical exams and obtain blood; if illness does occur, gather necessary respiratory information.
    • At age 2
      • Nasal swabs.
    • At age 3
      • Forced oscillation.
    • At age 4
      • Exhaled nitric oxide.
    • At age 5
      • Start spirometry.

Hypothesis 1 and 3: Indoor/Outdoor and Bioaerosols

Preconception––Exposures

  • Geographical location and association
    • Outdoor air pollution
    • Traffic
    • Pesticides (agricultural/non-agricultural areas)
    • Stationary sources (emissions inventory)
    • Meteorology
  • Occupation
  • Community–collective efficacy (ability to influence)
  • Cumulative/multi-chemical exposures (keep in mind geographical locations)

Pregnancy––Exposures

  • Ozone, particulate material (fine), diesel exhaust––criteria air pollutants. Rely on existing AP
  • Occupation/poverty level of neighborhood
  • Race, ethnicity, income of parents
  • ETS, mold, mildew, endotoxins (Qx recall), dust mites, pets, farm animals, and settled dust (vacuums)––all time integrated
  • Diarrheal infections
  • Other particulates­–candles, incense, and other materials.

Prenatal Measures–General Information in the First 3 Months and Early

  • Maternal health
  • Prenatal care
  • Access to health services
  • Prescription and OTC drugs
  • Illicit drugs
  • Herbal and traditional medicine
  • Paternal and maternal history of allergies
  • Glucose.

Postnatal Measures

  • Breast feeding history
  • Schedule of vaccination
  • Cleaning
  • Candles
  • Moving–change in residence
  • Indoor air measures–homes, daycare, and schools
  • Carbon dioxide
  • Ozone
  • VOCs–passive samples
  • Dust samples at different times of the year
  • Simple questions–past year
  • Parental occupation–changes
  • Geographical location
    • AP data in community
    • Don’t assume rural areas are covered
  • Traffic counts
  • Time outdoors
  • GIS and community specific.

Hypothesis 2 and 5: Non-Viral and Viral Infections

Prenatal Measures

  • Non-viral/viral infection of the mother
  • Vaginal swabs
  • Diarrheal infections (GIS).

Postnatal Measures–One Sample at 1 Year, 18 Months, 24 Months

  • RSV
  • Influenza
  • Rhinoviruses
  • Metapneumoviruses
  • Protusis (blood obtained)
  • Well­–baby check-ups
  • Diarrheal infections (GIS
  • Secretions–pediatricians can collect at check-ups and time of infections
  • Chlamydia or pneumonia
  • Viral or bacterial
  • Urinary tract infection (pregnant mother or child)
  • Stool sample at 1 year
  • H. pylori antibodies as a marker of exposure in the first year
  • Obtain blood.

Recommendations

  • William J. Rodriguez, FDA, suggested that the group standardize a questionnaire: Medical Symptoms––reflux, over the counter medications, stool sample, use of antibiotics, breast feeding practices, schedule of vaccination, ozone, sample day cares, and hand-washing (children).

Hypothesis 3: Measures of Stress–Maternal and Child Stress

Prenatal and Postnatal Measures

  • Cortisol swab
  • Perceived stress
  • Inter-pregnancy interval (complete pregnancy history)
  • Income
  • Community violence
  • Measurement to satisfaction of health care
  • Nutrition (antioxidants)
  • Social capital
  • Financial security
  • Lack of sleep
  • Friends
  • Family structure (conflict)
  • Parenting skills
  • Contact with non-custodial parent
  • Multiple caregivers.

Hypothesis 4: Antioxidant Constituents of Diet Decrease Risk of Asthma

Prenatal Measures––Diet at Conception and at Pregnancy

  • Omega 3
  • Fatty acids
  • Vitamin E
  • Blood obtained.

Postnatal Measures

  • Notes on breastfeeding every 2 months (real time)
  • Validation agents
  • Breast milk samples
  • Formulas (soy, rice, infant diet).

Postnatal Measures––Infants (Workshops)

  • WIC participant
  • Income level
  • Food stamps, food pantry
  • Supermarkets
  • Food allergens (nuts, milk, eggs)
  • Vitamin E
  • Toenails.

Hypothesis 6: Healthcare Systems

Not discussed.

In Attendance

Thematic Group Members

Chair: Grace K. LeMasters, Ph.D., University of Cincinnati
Audrey Burwell, Office of Minority Health, DHHS
Fernando A. Guerra, M.D., M.P.H., San Antonio Metropolitan Health District
Loretta Jones, M.A., Healthy African American Families
Sarah Keim, M.A., National Children’s Study Program Office, NICHD, NIH, DHHS
Stephanie London, M.D., Dr.P.H., NIEHS, NIH, DHHS
Jesse N. Marquez, Coalition For A Safe Environment
Fernando D. Martinez, M.D., University of Arizona, Tucson
Pauline Mendola, Ph.D., Office of Research and Development, EPA
Haluk Ozkaynak, Ph.D., M.S., EPA
Edith Ann Parker, Dr.P.H., University of Michigan School of Public Health
James J. Quackenboss, M.S., Office of Research and Development, EPA
William J. Rodriguez, M.D., Ph.D., FDA
Gary Sandefur, Ph.D., University of Wisconsin, Madison
Observers and Other Participants
Linda Dimitropoulos, Ph.D., RTI International
Maurice Owens, Ph.D., Science Applications International Corporation

  6/26/2008
  6/26/2008